IQVIA and Medera to Advance Cardiac Gene Therapy and Human-Based Drug Discovery

RESEARCH TRIANGLE PARK, N.C. & BOSTON--(BUSINESS WIRE)--IQVIA (NYSE:IQV), a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries, and Medera Inc. (“Medera”), a clinical-stage biopharmaceutical company pioneering next-generation therapeutics for cardiovascular disease, today announced a strategic collaboration to accelerate the development of cardiac gene therapies and human-based drug discovery platforms.

The collaboration brings together IQVIA’s global clinical trial and commercialization infrastructure with Medera’s pioneering platforms: Sardocor, focused on developing disease-modifying gene therapies for difficult-to-treat cardiovascular diseases, and Novoheart, a leader in engineered human-based cardiac tissue for disease modelling and drug screening.

Sardocor will leverage IQVIA’s regulatory and trial execution expertise to advance its FDA-cleared, first-in-human AAV-based gene therapy programs. IQVIA will support patient recruitment, data quality and regulatory filings, including applications for expedited FDA designations.

Novoheart’s mini-Heart platform is already instrumental in securing IND and Fast Track designations and offers a predictive, human-based alternative to animal testing. The platform is expanding into multiple organ systems to support drug discovery and safety testing under the FDA Modernization Act 2.0.

“By combining IQVIA’s global expertise with Medera’s mini-Heart platform and gene therapy programs, we can bring safer, more effective therapies to patients faster,” said Ronald Li, Co-Founder, Chairman & CEO of Medera. “This collaboration expands our reach, while reinforcing the scientific and regulatory momentum around human-based drug discovery and cardiac gene therapy innovation.”

About IQVIA

IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI^®, advanced analytics, the latest technologies and extensive domain expertise. IQVIA is committed to using AI responsibly, with AI-powered capabilities built on best-in-class approaches to privacy, regulatory compliance and patient safety, and delivering AI to the high standards of trust, scalability and precision demanded by the industry. With approximately 94,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.

About Medera Inc.

Medera is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat and currently incurable diseases by developing next-generation therapeutics. Medera operates via two business units: Sardocor, its clinical development arm advancing a pipeline of cardiac gene therapy trials (HFpEF, HFrEF, DMD-CM), and Novoheart, its preclinical subsidiary pioneering the world’s first and award-winning “mini-Heart” technology for human-based disease modelling, drug discovery, and toxicity testing. Novoheart’s platforms have already supported FDA IND and Fast Track designations, and the company is advancing a broader pipeline of gene therapy, cell therapy, and small molecule candidates. For more information, visit www.medera.bio.

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